Clinical Trials
At SciencePharma we provide state-of-the-art consultancy services in a field of clinical studies. We offer a high quality of services in agreement with valid law, the guidelines of the International Council for Harmonization (ICH), European Medicines Agency (EMA) guidelines, ISO standards and standard operating procedures (SOPs) developed within SciencePharma Quality Management System (QMS) dedicated to clinical trials conduct. The knowledge of registration requirements allows us to minimize time and costs associated with conduct of clinical studies.
We offer the following services:
- Performing feasibility of the planned study, finding proper clinical sites and investigators,
- Site and investigator contract negotiations;
- Preparation of complete study documentation required to be submitted via Clinical Trial Information System (CTIS), including:
- Study Protocol,
- Investigator’s Brochure,
- Subject Information Form and Informed Consent Form,
- Case Report Form,
- Investigational Medicinal Product Dossier (also for Advanced Therapy Medicinal Products (ATMPs))
- Communication with Experts from the Agency evaluating documentation and responding to Request for Information (RFI);
- Providing the high quality of clinical trial monitoring services;
- Supervision on bioanalytical laboratories, validation and analysis of study samples;
- Conduct of subcontractors’ audits, nonclinical and clinical sites audits;
- Providing a full range of data management services, including database design and its validation, generation and entering data into database, quality control, MedDRA coding, query generation and database close-out;
- Preparation or verification of clinical, bioanalytical, statistical or integrated study report in compliance with ICH E3 guideline, as well as ISO standard and relevant legal requirements in case of clinical investigation report for medical devices.